CY1106148T1 - PHARMACEUTICAL COMPOSITION PEPILAMVANOUS N-((1-N-BUTYL-4-PIPEPIDINYL) METHYL)-3,4-DIHYDRO-2H-(1,3)OXAZINO(3,2-A)INDOLE-10-CARBOXAMIDE OR SALT AND METHOD FOR FRIDAY SHE RECEIVING DRY GRANULATION - Google Patents

PHARMACEUTICAL COMPOSITION PEPILAMVANOUS N-((1-N-BUTYL-4-PIPEPIDINYL) METHYL)-3,4-DIHYDRO-2H-(1,3)OXAZINO(3,2-A)INDOLE-10-CARBOXAMIDE OR SALT AND METHOD FOR FRIDAY SHE RECEIVING DRY GRANULATION

Info

Publication number
CY1106148T1
CY1106148T1 CY20061101205T CY061101205T CY1106148T1 CY 1106148 T1 CY1106148 T1 CY 1106148T1 CY 20061101205 T CY20061101205 T CY 20061101205T CY 061101205 T CY061101205 T CY 061101205T CY 1106148 T1 CY1106148 T1 CY 1106148T1
Authority
CY
Cyprus
Prior art keywords
salt
dry granulation
pharmaceutical composition
granules
oxazino
Prior art date
Application number
CY20061101205T
Other languages
Greek (el)
Inventor
Philip Christopher Buxton
Sharon E. Groves
Seona Thomson
Dirk Marinus J. Van Schie
Kenneth T. Yeates
Original Assignee
Glaxo Group Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from GB0203526A external-priority patent/GB0203526D0/en
Priority claimed from GB0203528A external-priority patent/GB0203528D0/en
Application filed by Glaxo Group Limited filed Critical Glaxo Group Limited
Publication of CY1106148T1 publication Critical patent/CY1106148T1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/02Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/02Non-specific cardiovascular stimulants, e.g. drugs for syncope, antihypotensives

Abstract

Η εφεύρεση παρέχει μέθοδο για παρασκευή μιας φαρμακευτικής σύνθεσης που περιλαμβάνει Ν-((1-κβουτυλ-4-πιπεριδινυλ)μεθυλ]-3,4-διϋδρο-2Η-(1,3)οξαζινο[3,2-a]ινδολο-10-καρβοξαμίδιο (SB 207266) (piboserod) ή φαρμακευτικώς αποδεκτό άλας αυτού σε συνδυασμό με ένα ή περισσότερα φαρμακευτικώς αποδεκτά έκδοχα, η δε μέθοδος περιλαμβάνει σχηματισμό τμήματος ή του συνόλου του SB 207266 ή του άλατος αυτού σε κόκκους με μια μέθοδο ξηρής κοκκοποίησης. Η μέθοδος κατά προτίμηση είναι μια μέθοδος συμπίεσης κυλίνδρου, που ακολουθείται κατά προτίμηση από άλεση προς κατάλληλο μέγεθος σωματιδίου. Οι κόκκοι συνήθως είναι αυξημένου μεγέθους σωματιδίου ή/και συμπιεσμένοι εν συγκρίσει προς το SB 207266 ή το άλας αυτού. Κατά προτίμηση, το SB 207266 ή το άλας αυτού υπάρχει στη σύνθεση ή/και στους κόκκους σε τουλάχιστον 4 % κατά βάρος ή/και μέχρι 60% κατά βάρος της σύνθεσης ή/και κατά βάρος των κόκκων αντιστοίχως. Ένα ενδοκοκκώδες λιπαντικό, πληρωτικό (π.χ., CaHPO4) ή/και βοηθητικό συμπίεσης (π.χ., μικροκρυσταλλική κυτταρίνη) χρησιμοποιούνται συνήθως. Η εφεύρεση παρέχει επίσης μια φαρμακευτική σύνθεση λαμβανόμενη με τη μέθοδο ξηρής κοκκοποίησης ή/και η οποία έχει παρασκευασθεί με τη μέθοδο ξηρής κοκκοποίησης.The invention provides a method for preparing a pharmaceutical composition comprising N-((1-butyl-4-piperidinyl)methyl]-3,4-dihydro-2H-(1,3)oxazino[3,2-a]indole-10 -carboxamide (SB 207266) (piboserod) or a pharmaceutically acceptable salt thereof in combination with one or more pharmaceutically acceptable excipients, the method comprising forming part or all of SB 207266 or its salt into granules by a dry granulation method. preferably is a roll compression method, preferably followed by milling to an appropriate particle size. The granules are typically of increased particle size and/or compressed compared to SB 207266 or its salt. Preferably, SB 207266 or its salt thereof is present in the composition and/or in the granules at least 4% by weight and/or up to 60% by weight of the composition and/or by weight of the granules respectively An intragranular lubricant, filler (e.g., CaHPO4) and/or compression aid (eg, microcrystalline cellulose) are commonly used. The invention also provides a pharmaceutical composition obtained by the dry granulation method and/or which has been prepared by the dry granulation method.

CY20061101205T 2002-02-14 2006-08-28 PHARMACEUTICAL COMPOSITION PEPILAMVANOUS N-((1-N-BUTYL-4-PIPEPIDINYL) METHYL)-3,4-DIHYDRO-2H-(1,3)OXAZINO(3,2-A)INDOLE-10-CARBOXAMIDE OR SALT AND METHOD FOR FRIDAY SHE RECEIVING DRY GRANULATION CY1106148T1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB0203526A GB0203526D0 (en) 2002-02-14 2002-02-14 Process and composition
GB0203528A GB0203528D0 (en) 2002-02-14 2002-02-14 Process and composition
PCT/GB2003/000217 WO2003068193A1 (en) 2002-02-14 2003-01-22 Pharmaceutical composition comprising n- ((1-n-butyl-4-piperidinyl) methyl)-3, 4-dihydro-2h- (1, 3) oxazino (3, 2-a) indole-10-carboxamide or salt and process therefor comprising dry granulation

Publications (1)

Publication Number Publication Date
CY1106148T1 true CY1106148T1 (en) 2011-06-08

Family

ID=27736214

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20061101205T CY1106148T1 (en) 2002-02-14 2006-08-28 PHARMACEUTICAL COMPOSITION PEPILAMVANOUS N-((1-N-BUTYL-4-PIPEPIDINYL) METHYL)-3,4-DIHYDRO-2H-(1,3)OXAZINO(3,2-A)INDOLE-10-CARBOXAMIDE OR SALT AND METHOD FOR FRIDAY SHE RECEIVING DRY GRANULATION

Country Status (22)

Country Link
US (1) US20050075335A1 (en)
EP (1) EP1476136B1 (en)
JP (1) JP2005523276A (en)
KR (1) KR100967782B1 (en)
AT (1) ATE329581T1 (en)
AU (1) AU2003202058B2 (en)
BR (1) BR0307666A (en)
CA (1) CA2475659A1 (en)
CO (1) CO5611095A2 (en)
CY (1) CY1106148T1 (en)
DE (1) DE60306120T2 (en)
DK (1) DK1476136T3 (en)
ES (1) ES2263949T3 (en)
HK (1) HK1072359A1 (en)
IS (1) IS2393B (en)
MX (1) MXPA04007857A (en)
NO (1) NO20043834L (en)
NZ (1) NZ534333A (en)
PL (1) PL206544B1 (en)
PT (1) PT1476136E (en)
RU (1) RU2329789C2 (en)
WO (1) WO2003068193A1 (en)

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GB0211230D0 (en) 2002-05-16 2002-06-26 Medinnova Sf Treatment of heart failure
CA2406592C (en) * 2002-10-04 2003-09-30 Duchesnay Inc. Method of preparing pharmaceutical dosage forms containing multiple active ingredients
AR050253A1 (en) 2004-06-24 2006-10-11 Smithkline Beecham Corp COMPOSITE DERIVED FROM INDAZOL CARBOXAMIDE, COMPOSITION THAT INCLUDES IT AND ITS USE FOR THE PREPARATION OF A MEDICINAL PRODUCT
US8063071B2 (en) 2007-10-31 2011-11-22 GlaxoSmithKline, LLC Chemical compounds
RU2008147668A (en) * 2006-05-04 2010-06-10 Новартис АГ (CH) METHOD FOR PRODUCING PHARMACEUTICAL COMPOSITIONS BY PRESSING BY HEATED ROLLERS
AR065804A1 (en) 2007-03-23 2009-07-01 Smithkline Beecham Corp COMPOSITE OF INDOL CARBOXAMIDE, PHARMACEUTICAL COMPOSITION THAT UNDERSTANDS IT AND USE OF THIS COMPOUND TO PREPARE A MEDICINAL PRODUCT
DK2170292T3 (en) * 2007-06-22 2014-04-07 Bristol Myers Squibb Holdings Ireland Tablet-containing Atazanavir Compositions
CN101772304B (en) * 2007-07-31 2014-07-09 卡吉尔公司 Direct compressible dextrose
US8354539B2 (en) 2009-03-10 2013-01-15 Glaxo Group Limited Indole derivatives as IKK2 inhibitors
TW201129386A (en) * 2009-11-05 2011-09-01 Fmc Corp Microcrystalline cellulose and calcium phosphate compositions useful as pharmaceutical excipients
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US9606054B2 (en) 2013-09-30 2017-03-28 Advantest Corporation Methods, sampling device and apparatus for terahertz imaging and spectroscopy of coated beads, particles and/or microparticles
US9417181B2 (en) * 2014-05-08 2016-08-16 Advantest Corporation Dynamic measurement of density using terahertz radiation with real-time thickness measurement for process control
KR101545268B1 (en) 2015-02-05 2015-08-20 보령제약 주식회사 Tablet and method of preparing the same
WO2016126012A1 (en) * 2015-02-05 2016-08-11 Boryung Pharmaceutical Co., Ltd Tablet and method of preparing the same
CN104945303B (en) * 2015-06-15 2017-09-29 浙江工业大学 The preparation method of 3 alkenyl Benzazole compounds
AU2021260109A1 (en) * 2020-04-24 2022-12-15 Astrazeneca Ab Pharmaceutical formulations
KR102499289B1 (en) * 2022-04-15 2023-02-14 주식회사 비에스앤코 Manufacturing method of powder toothpaste

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Also Published As

Publication number Publication date
RU2004127450A (en) 2005-04-10
EP1476136B1 (en) 2006-06-14
BR0307666A (en) 2005-01-11
NO20043834L (en) 2004-10-26
RU2329789C2 (en) 2008-07-27
AU2003202058B2 (en) 2009-05-28
IS2393B (en) 2008-08-15
CA2475659A1 (en) 2003-08-21
MXPA04007857A (en) 2004-10-15
DE60306120T2 (en) 2006-11-09
CO5611095A2 (en) 2006-02-28
PT1476136E (en) 2006-10-31
EP1476136A1 (en) 2004-11-17
PL371963A1 (en) 2005-07-11
DK1476136T3 (en) 2006-10-09
WO2003068193A1 (en) 2003-08-21
PL206544B1 (en) 2010-08-31
NZ534333A (en) 2006-05-26
ES2263949T3 (en) 2006-12-16
DE60306120D1 (en) 2006-07-27
KR100967782B1 (en) 2010-07-05
US20050075335A1 (en) 2005-04-07
KR20040097996A (en) 2004-11-18
ATE329581T1 (en) 2006-07-15
IS7398A (en) 2004-08-12
AU2003202058A1 (en) 2003-09-04
HK1072359A1 (en) 2005-08-26
JP2005523276A (en) 2005-08-04

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